FDA.reportPublic FDA data

Alive Prebiotic Balancing Moisturizer SPF 15

Manufacturer
Algenist, LLC
Effective date
2018-09-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:54

Label at a glance#

ProductAlive Prebiotic Balancing Moisturizer SPF 15
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply to the entire face, neck, and décolleté, avoiding the eye area, in the morning. Use only as directed. Apply liberally to the entire face in the morning or 15 minutes prior to sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor Apply to clean face with fingertips or brush and blend well. Layer for additional coverage as need...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13.65%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

  • Stop use and consult a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to the entire face, neck, and décolleté, avoiding the eye area, in the morning. Use only as directed. Apply liberally to the entire face in the morning or 15 minutes prior to sun exposure

  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: Ask a doctor
  • Apply to clean face with fingertips or brush and blend well. Layer for additional coverage as needed.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua, Eau), Caprylic/ Capric Triglyceride, Coco-Caprylate, Glycerin, Glyceryl Behenate, Coco-Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Glyceryl Caprylate, Sodium Stearoyl Glutamate, Parachlorella Beijerinckii Exopolysaccharides, Chlorella Vulgaris Extract, Lactococcus Ferment Lysate, Alteromonas Ferment Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Microcrystalline Cellulose, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Butylene Glycol, Isostearic Acid, Caprylhydroxamic Acid, Algin, Calcium Alginate, Propanediol, Maltodextrin, Lactic Acid, Sodium Benzoate, Sodium Chloride.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions

OTC - QUESTIONS SECTION

Call toll free 1-877-650-1837

Principal Display Panel - 10 mL Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALIVE

Prebiotic Balancing
Moisturizer SPF 15

Soin Prébiotique
Équilibrant FPS 15

Broad Spectrum
Sunscreen SPF 15

Écran Solaire Large
Spectre FPS 15

ALGENIST
Alguronic Acid + Prebiotic

0.34 US fl. oz. / 10 ml

Principal Display Panel - 10 mL Box Label
Principal Display Panel - 10 mL Box Label

Principal Display Panel - 50 mL Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALIVE

Prebiotic Balancing
Moisturizer SPF 15

Soin Prébiotique
Équilibrant FPS 15

Broad Spectrum
Sunscreen SPF 15

Écran Solaire Large
Spectre FPS 15

ALGENIST
Alguronic Acid + Prebiotic

1.7 US fl. oz. / 50 ml

Principal Display Panel - 50 mL Box Label
Principal Display Panel - 50 mL Box Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71047-262-102020-01-31C16284748780-19d75b9d0-bb93-f424-e053-dadaa90a57ceDrug Facts
71047-262-502020-01-31C16284748780-19d75b9d0-bb93-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71047-262-10Alive Prebiotic Balancing Moisturizer SPF 151 in 1 BOXLOTION12
71047-262-10Alive Prebiotic Balancing Moisturizer SPF 1510 mL in 1 TUBELOTION102
71047-262-50Alive Prebiotic Balancing Moisturizer SPF 151 in 1 BOXLOTION12
71047-262-50Alive Prebiotic Balancing Moisturizer SPF 1550 mL in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71047-262ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15 (ZINC OXIDE) LOTION [ALGENIST, LLC]2Legacy NDC, 4 package rows20180927_80486f96-4381-4707-bd73-1cb1d3f6a2d2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71047-26271047-262-50, 71047-262-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
COCO GLUCOSIDEICS790225BIACT
JOJOBA OIL724GKU717MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CAPRYLYL GLYCOL00YIU5438UIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISOSTEARIC ACIDX33R8U0062IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SODIUM ALGINATEC269C4G2ZQIACT
CALCIUM ALGINATE8P20S56HZIIACT
PROPANEDIOL5965N8W85TIACT
MALTODEXTRIN7CVR7L4A2DIACT
CHLORELLA VULGARISRYQ4R60M02IACT
CAESALPINIA SPINOSA FRUIT PODEXY4496LWDIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2d428961-384e-4894-b270-85bf6f41d5cd80486f96-4381-4707-bd73-1cb1d3f6a2d22018-09-14WarningsExact identifier
spl id: 2d428961-384e-4894-b270-85bf6f41d5cd
spl set id: 80486f96-4381-4707-bd73-1cb1d3f6a2d2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.